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Alkylating agents

Carboplatin vs Olaparib for Prostate Cancer (COBRA Trial)

Phase 2

Recruiting

Led By Robert B. Montgomery, MD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

mCRPC as defined by serum testosterone < 50 ng/ml (for patients on GnRH analogues or antagonists) and at least one of the following:

Progression of metastatic bone disease on bone scan, CT or MRI with > 2 new lesions

Must not have

Currently receiving active therapy for other neoplastic disorder(s)

Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through duration of the study, up to six years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing the efficacy of two treatments for patients with metastatic castrate resistant prostate cancer who have tumors containing BRCA1, BRCA2 or PALB2 inactivating DNA mutations.

Who is the study for?

Men over 18 with advanced prostate cancer that's resistant to hormone therapy and has specific gene mutations (like BRCA1/2). They must have ongoing hormone treatment, measurable disease progression, normal organ/bone marrow function, no brain metastasis or other cancers being treated, and not taken certain drugs before.

What is being tested?

The trial compares carboplatin chemotherapy to olaparib pills for men with a type of advanced prostate cancer. Patients are randomly chosen to start with one drug and can switch to the other if the first one stops working. The study checks how well each drug controls the cancer.

What are the potential side effects?

Olaparib may cause nausea, fatigue, anemia, blood clots while carboplatin can lead to nerve damage, kidney problems, allergic reactions. Side effects vary by individual and should be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My prostate cancer is resistant to medical or surgical treatments to lower testosterone.

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My scans show my bone cancer has worsened with more than 2 new spots.

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I have been treated with medications like abiraterone, enzalutamide, apalutamide, or darolutamide.

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I am mostly self-sufficient and can carry out daily activities.

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My cancer has specific mutations (RAD51B/C/D or RAD54L) confirmed by a certified test.

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I am on hormone therapy for cancer or have had surgery to remove my testicles.

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I am a man older than 18.

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I have been diagnosed with prostate cancer, but it's not the small-cell or high-grade neuroendocrine type.

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My kidneys work well enough, based on a specific calculation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently undergoing treatment for another cancer.

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I have been diagnosed with myelodysplastic syndrome or acute myeloid leukemia.

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I have been treated with platinum, mitoxantrone, or PARP inhibitors for prostate cancer.

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I do not have active hepatitis or severe liver disease.

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I have had a heart attack or serious heart disease in the last 6 months.

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I am not taking strong or moderate CYP3A inhibitors, or I can stop them for 2 weeks before starting olaparib.

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I am not currently using, or have stopped using strong or moderate drugs that affect liver enzymes as required before starting olaparib.

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I cannot swallow pills or have stomach issues affecting medication absorption.

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I have brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through duration of the study, up to six years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through duration of the study, up to six years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through duration of the study, up to six years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS-1L) defined as the time interval between randomization and first documented disease progression or death due to any cause reported during, or after, first-line treatment.

Secondary study objectives

Grade 3 and 4 toxicities in first and second-line setting

PSA measurements/response

time interval between randomization and second documented disease progression during or after second-line or death (due to any cause)

Other study objectives

Exploratory Objective - PFS

Exploratory Objective - objective response rate

Exploratory Objective- objective duration of response

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: Treatment Arm 2 - Olaparib to CarboplatinActive Control2 Interventions

Participants are prescribed olaparib which is taken orally at home, twice daily, 300 mg in 28 day cycles, as first line therapy. For second line (crossover), carboplatin is administered AUC 5 IV every 21 days thereafter.

Group II: Treatment Arm 1 - Carboplatin to OlaparibActive Control2 Interventions

Participants are administered carboplatin AUC 5 IV first, which is administered Cycle-1, Day-1, and then every 21 days as first line therapy. For second line (crossover), olaparib is prescribed and taken orally at home, twice daily, 300 mg in 28 day cycles.

0 / 18Eligibility criteria met